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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K874567
Device Name RESUSCITATOR
Applicant
American Medical Technology, Inc.
C/O Venture Mgmt Consulting
Box 160 Grand View Ter. Ext
Brooklyn,  CT  06234
Applicant Contact GENE ZAMBA
Correspondent
American Medical Technology, Inc.
C/O Venture Mgmt Consulting
Box 160 Grand View Ter. Ext
Brooklyn,  CT  06234
Correspondent Contact GENE ZAMBA
Regulation Number868.5915
Classification Product Code
BTM  
Date Received11/05/1987
Decision Date 02/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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